Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963672
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-06-19
Brief Title:
Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures Application in Intensive Care Unit
Sponsor:
Poitiers University Hospital
Organization:
Poitiers University Hospital
Study Overview
Official Title:
Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures Application in Intensive Care Unit SleepScan
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SleepScan
Brief Summary:
Sleep of critically ill patients is highly disturbed with a high sleep fragmentation patients spend most of their sleep in very short sleep episodes lasting less than 10 minutes Causes of theses sleep alterations are complex including environmental noise alarms beepers conversations continuous light nurse care and repetitive measures of vital parameters
Numerous studies have reported a relationship between severe sleep alterations and a prolonged weaning period and mortality Improving sleep quality in critically ill patients is a major challenge to promote ICU patients recovery
A very promising treatment is the application of a nocturnal quiet-time during which non urgent care comfort care systematic measures of vital parameters are delayed and clustered in order to limit room entries However quiet time procedures have failed to improve sleep quality to date
A miniaturized medical device recording one EEG channel and embedding an automated sleep scoring algorithm running in real-time was devised This device positioned on forehead and continuously recording noise and light levels indicates if the patient is awake or asleep using a tablet positioned at doorstep of the room so that nurses know if patient is sleeping without entering the room
Hypothesis proposes that applying sleep protection procedures clustering cares limiting room entries reducing lights and noise delaying non urgent care when patients are sleeping EEG-guided strategies will increase patients sleep quality
This study will assess the effect of such device on sleep quality in ICU patients This is a before after design The first group control group will be recorded but the sleep scoring will not be displayed by the tablet and patient will be expose to standard care Then procedure will be established collegially with nurses nurses assistants and doctors Then the second group treated group will be recorded with the device displaying the status of the patient asleepawake and all caregivers will be asked to follow the established rules EEG-guided sleep protection rules
Numerous studies have reported a relationship between severe sleep alterations and a prolonged weaning period and mortality Improving sleep quality in critically ill patients is a major challenge to promote ICU patients recovery
A very promising treatment is the application of a nocturnal quiet-time during which non urgent care comfort care systematic measures of vital parameters are delayed and clustered in order to limit room entries However quiet time procedures have failed to improve sleep quality to date
A miniaturized medical device recording one EEG channel and embedding an automated sleep scoring algorithm running in real-time was devised This device positioned on forehead and continuously recording noise and light levels indicates if the patient is awake or asleep using a tablet positioned at doorstep of the room so that nurses know if patient is sleeping without entering the room
Hypothesis proposes that applying sleep protection procedures clustering cares limiting room entries reducing lights and noise delaying non urgent care when patients are sleeping EEG-guided strategies will increase patients sleep quality
This study will assess the effect of such device on sleep quality in ICU patients This is a before after design The first group control group will be recorded but the sleep scoring will not be displayed by the tablet and patient will be expose to standard care Then procedure will be established collegially with nurses nurses assistants and doctors Then the second group treated group will be recorded with the device displaying the status of the patient asleepawake and all caregivers will be asked to follow the established rules EEG-guided sleep protection rules
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None